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FDA 510(k)

BLOOD MONITORING UNIT, MODEL BMU 40

K-Number: K090147 · 2009-04-22

ApplicantMaquet Cardiopulmonary, AG
Decision Date2009-04-22
Product CodeDRY
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

BLOOD MONITORING UNIT, MODEL BMU 40 is the device name listed in this FDA 510(k) record. The listed applicant is Maquet Cardiopulmonary, AG. It received FDA 510(k) clearance on 2009-04-22 under 510(k) number K090147. The device is classified under product code DRY. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the BLOOD MONITORING UNIT, MODEL BMU 40?

BLOOD MONITORING UNIT, MODEL BMU 40 is a medical device that received FDA 510(k) clearance on 2009-04-22. The listed applicant is Maquet Cardiopulmonary, AG. The 510(k) number is K090147.

When did BLOOD MONITORING UNIT, MODEL BMU 40 receive FDA 510(k) clearance?

BLOOD MONITORING UNIT, MODEL BMU 40 received FDA 510(k) clearance on 2009-04-22, under 510(k) number K090147.

Who is the listed applicant for BLOOD MONITORING UNIT, MODEL BMU 40?

The FDA 510(k) record lists Maquet Cardiopulmonary, AG as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for BLOOD MONITORING UNIT, MODEL BMU 40?

The FDA product code for BLOOD MONITORING UNIT, MODEL BMU 40 is DRY.

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Other records listing Maquet Cardiopulmonary, AG as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K133265QUADROX-IR ADULT AND SMALL ADULTK132166VENOUS HARDSHELL CARDIOTOMY RESERVOIR; NON-COATED, NON-TIGHT/ VACUUM-TIGHT/ WITH SOFTLINE COATING, VACUUM-TIGHTK132829QUADROX-I, QUADROX-ID, QUADROX-IR OXYGENATORSK131666ARTERIAL HLS CANNULA 13 FR NON-COATED, WITH BIOLINE COATING AND WITH SOFTLINE COATINGK130300HEATER-COOLER UNIT HCU 40K123288HEMOCONCENTRATOR

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Related Devices (Code: DRY)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K234065CDI OneView Monitoring SystemTerumo Cardiovascular Systems CorporationK202154B-CaptaLivanova Deutschland, GmbHK202557Quantum Workstation 12 EliteSpectrum Medical , Ltd.K182110CDI Blood Parameter Monitoring System 550Terumo Cardiovascular Systems CorporationK181923Quantum Workstation 12.1Spectrum Medical , Ltd.K173591Quantum Diagnostic Module, Quantum Diagnostic Module - No GasSpectrum Medical , Ltd.

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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